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Spots Global Cancer Trial Database for Safety and Efficacy of ATIR101 as Adjunctive Treatment to Blood Stem Cell Transplantation From a Haploidentical Family Donor Compared to Post-transplant Cyclophosphamide in Patients With Blood Cancer

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Trial Identification

Brief Title: Safety and Efficacy of ATIR101 as Adjunctive Treatment to Blood Stem Cell Transplantation From a Haploidentical Family Donor Compared to Post-transplant Cyclophosphamide in Patients With Blood Cancer

Official Title: A Phase III, Multicenter, Randomized Controlled Study to Compare Safety and Efficacy of a Haploidentical HSCT and Adjunctive Treatment With ATIR101, a T-lymphocyte Enriched Leukocyte Preparation Depleted ex Vivo of Host Alloreactive T-cells, Versus a Haploidentical HSCT With Post-transplant Cyclophosphamide in Patients With a Hematologic Malignancy

Study ID: NCT02999854

Study Description

Brief Summary: The primary objective of this study is to compare safety and efficacy of a haploidentical T-cell depleted HSCT and adjunctive treatment with ATIR101 versus a haploidentical T cell replete HSCT with post-transplant administration of high dose cyclophosphamide (PTCy) in patients with a hematologic malignancy. An additional objective of the study is to compare the effect of the two treatments on quality of life.

Detailed Description: Study CR-AIR-009 is a Phase III randomized controlled multicenter open-label study comparing two parallel groups. After signing informed consent, a total of 250 patients will be randomized in a 1:1 fashion to receive either a T-cell depleted hematopoietic stem cell transplantation (HSCT; CD34 selection) from a related, haploidentical donor, followed by ATIR101 infusion, or a T-cell replete HSCT, followed by a high dose of post-transplant cyclophosphamide (PTCy). Randomization will use minimization to balance treatment groups with respect to underlying disease (AML, ALL, or MDS), Disease Risk Index (DRI; intermediate risk, high risk, or very high risk) and center. A stochastic treatment allocation procedure will be used so that the treatment assignment is random for all patients entered in the study. Patients randomized in the ATIR101 group will receive a single ATIR101 dose of 2×10E6 viable T-cells/kg between 28 and 32 days after the HSCT. Patients randomized in the PTCy group will receive cyclophosphamide 50 mg/kg/day at 3 and 4/5 days after the HSCT. All patients will be followed up for at least 24 months post HSCT.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

City of Hope National Medical Center, Duarte, California, United States

Moores UC San Diego Cancer Center, La Jolla, California, United States

UCLA Center for Health Sciences, Los Angeles, California, United States

Stanford University School of Medicine, Stanford, California, United States

Emory University, Atlanta, Georgia, United States

University of Kansas Cancer Center, Westwood, Kansas, United States

Massachusetts General Hospital, Boston, Massachusetts, United States

University of Michigan, Ann Arbor, Michigan, United States

Weill Cornell Medical College, New York, New York, United States

Columbia University Medical Center, New York, New York, United States

Stony Brook University Hospital, Stony Brook, New York, United States

Oregon Health & Science University, Portland, Oregon, United States

Universitair Ziekenhuis Antwerpen, Antwerp, , Belgium

Algemeen Ziekenhuis Sint-Jan, Brugge, , Belgium

Institut Jules Bordet, Brussels, , Belgium

Universitair Ziekenhuis Gasthuisberg, Leuven, , Belgium

Centre Hospitalier Universitaire de Liège, Liège, , Belgium

Maisonneuve-Rosemont Hospital, Montreal, Quebec, Canada

University Hospital Centre Zagreb, Zagreb, , Croatia

APHP Hospital Saint Louis, Paris, , France

University Hospital Frankfurt, Goethe University, Frankfurt, , Germany

University Medical Center Mainz, Mainz, , Germany

Ludwig-Maximilians-University Hospital of Munich-Grosshadern, Munich, , Germany

Universitätsklinikum Würzburg, Würzburg, , Germany

Rambam Medical Center, Haifa, , Israel

Hadassah Medical Center & Hadassah Hospital Ein Karem, Jerusalem, , Israel

Sourasky Medical Center & Tel Aviv University, Tel Aviv, , Israel

Chaim Sheba Medical Center, Tel-Hashomer, , Israel

Milano Hospital, Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico, Milano, , Italy

Fondazione IRCCS Policlinico San Matteo, Pavia, , Italy

Academisch Ziekenhuis Maastricht, Maastricht, , Netherlands

Faculdade de Medicina da Universidade de Lisboa, Lisboa, , Portugal

University Hospital Barcelona Vall d' Hebron, Barcelona, , Spain

Hospital Puerta de Hierro Majadahonda, Madrid, , Spain

UGC Hematología y Hemoterapia, Sevilla, , Spain

Servicio de Hematología Hospital, Universitari I politècnic La Fe, Valencia, , Spain

Karolinska University Hospital, Stockholm, , Sweden

Heartlands Hospital, Birmingham, , United Kingdom

St James University Hospital, Leeds, , United Kingdom

Royal Liverpool University Hospital, Liverpool, , United Kingdom

Hammersmith Hospital, London, , United Kingdom

Manchester Royal Infirmary, Manchester, , United Kingdom

Contact Details

Name: Denis Claude Roy, Prof MD

Affiliation: Research Center and Cellular Therapy Laboratory, Maisonneuve-Rosemont Hospital (Montreal, Canada)

Role: PRINCIPAL_INVESTIGATOR

Name: Stephan Mielke, Prof MD

Affiliation: Centre for Allogeneic Stem Cell Transplantation, Karolinska University Hospital (Stockholm, Sweden)

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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